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Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management
Sponsor: Centre Hospitalier Universitaire de Besancon
Summary
This study aims to demonstrate, during the first standard surgical management of patients with stage II MRONJ, the effect of the implantation of a cryopreserved hAM on the maxillomandibular bone, on the healing of the oral mucosa.
Official title: Benefit of Cryopreserved Human Amniotic Membrane (hAM) on Oral Mucosal Healing Among Patients With Stage II Maxillomandibular Osteonecrosis Induced by Antiresorptive and/or Anti-angiogenic Therapies: a Phase II Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2023-09-22
Completion Date
2026-03
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Human Amniotic Membrane
After conventional/standard treatment, hAM will be applied in a single layer against the bone defect with, if possible, a burial of a few millimeters under the mucous edges. With the idea of apprehending a possible dose effect, the hAM will be adapted to the size of the bone/mucous defect, mesenchymal side against the bone. For closure after hAM grafting : 2 options are possible: Edge-to-edge closure if sufficient mucosal laxity, Edge rapprochement by cross points. If necessary: possible incision of the periosteum to give laxity to the mucosa.
Conventional/Standard treatment
Surgical procedure: Endo-oral approach: * Trimming of the mucous edges if they are necrotic or inflamed (granulation tissue) * For the bone: either simple sequestrectomy (the mobile sequestered bone is grabbed using forceps); either reaming until bleeding is obtained; either resection with the rongeur; either monobloc resection of the entire necrotic fragment with a saw or with a piezzotome (ultrasound); or a combination of different techniques. Rq: the resection of the necrotic bone (according to the practices of the center) will operate until the appearance of an "apparently healthy" bone (bone bleeding, clean appearance of the bone site) * Closure of the mucosa with possible incision of the periosteum to provide laxity: Suture points by points separated in one plane with non-absorbable braided thread of the 3.0 "silk thread" type and round needle.
Locations (5)
CHU de Besancon
Besançon, France
CHU Bordeaux Pellegrin
Bordeaux, France
CHU de Dijon
Dijon, France
CHR Metz Thionville
Metz, France
CHU de Reims
Reims, France